06Feb 2020

Recently, the Supreme Court once again refused to take up cases involved in the 101 statute (patentable subject matter). 

Many briefs were filed by the industry, academics, and the government to urge the Supreme Court to update and clarify what is patentable and what is not patentable. The refusal to intervene may be a signal to Congress that it should be up to them to decide on the matter. 

Continue reading
24Jan 2020

The Safe Harbor Provision of 35 U.S.C. § 271(e)(1) states that:

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site-specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

In a recent infringement case, Amgen v. Hospira, the allegedly infringed patents related to cells that stimulate the creation of red blood cells in anemia patients and a method of preparing erythropoietin (EPO). 

Continue reading
30Oct 2019

A few weeks ago (mid-October 2019), the USPTO released an updated (view here) patent subject matter eligibility guidance (PEG) along with new examples related to personalized medicine, therapeutic methods, and pharmaceutical products.  

The October update is essentially a clarification of the January 2019 guidance.

This update analyzes five areas of the 35 U.S.C. §101 analysis and procedure in detail, and is accompanied by four new hypothetical § 101 examples, an index of all such examples published since early 2015, and an updated spreadsheet of § 101 court cases.  

Continue reading
30Sep 2019
Silvia Salvadori Blog Article

Recently, in Mayo Foundation for Medical Education and Research v. Iancu, the Federal Circuit agreed with the U.S. Patent and Trademark Office (USPTO) with regard to the Patent Term Adjustment (PTA) for U.S. Patent No. 8,981,063. The issue was whether the interpretation of “any time consumed by continued examination of the application requested by the applicant” was correct.

Continue reading